Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:06 AM
Study NCT ID:
NCT04016220
Status:
UNKNOWN
Last Update Posted:
2019-07-11
First Post:
2019-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nebulized Budesonide Combined With Systemic Corticosteroid in Acute Severe Asthma
Sponsor:
University of Monastir
Organization:
Study Overview
Official Title:
Nebulized Budesonide Combined With Systemic Corticosteroid in Acute Severe Asthma Managed in the Emergency Department: A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our study is a prospective double-blind randomized study performed in the Emergency Department (ED). The objective of our study was to demonstrate the additive effect of high and repeated doses of inhaled budesonide combined with the standard treatment of acute asthma in adult managed in the ED
Detailed Description:
Patients were included in a double-blind, randomized into one of two groups. The experimental group received a first nebulization of 5 mg of terbutaline (Bricanyl®, AstraZeneca : solution of 5mg/ 2 ml ) in association with 0.5 mg of ipratropium bromide (Ipratropium®, AGUETTANT, solution of 0.5 mg/ 2 ml) and 0.5 mg of budesonide (Pulmicort®, AstraZeneca, solution of 0.5 mg/2 ml) followed by repetitive nebulization of 5 mg of terbutaline with 0.5 mg of budesonide at 20, 40, 60 and 120 min. The control group received a first nebulization of 5 mg of terbutaline in association with 0.5 mg of ipratropium bromide and 2 ml of normal saline followed by a repetitive nebulization of 5 mg de terbutaline with 2 ml of normal saline at 20, 40, 60 and 120 min (Figure 1). The placebo and the budesonide were prepared by the pharmacist. All patients received hydrocortisone hemisuccinate (100 mg i.v.) and O2 (7 l/ min) via a nebulizer (Mini nebulizer 40-115510; Peters, France).
Measure The following parameters were measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation: peak expiratory flow (PEF), respiratory rate (RR), heart rate (HR), dyspnea scale, systolic and diastolic blood pressure. PEF was measured with peak flow meter (mini-Wright; Clement Clarke; Harlow, UK). The highest of three values was recorded. HR was measured from continuous monitor. Dyspnea was assessed by the patient's own sensation of respiratory difficulty with a value assigned on a scale of 0 to 3, in which 0 denoted absent, 1 mild, 2 moderate, and 3 severe. At the end of the treatment, the patient was asked to indicate the presence or absence of each of five symptoms: palpitations, tremor, anxiety, headache, and dry mouth. Also, an interviewer determined the duration of symptoms before presentation, which specifically included how long the patient had been wheezing and shorter of breath than usual; a decline in the PEF, if available, was considered. The occurrence of a worsening of ventilator status requiring mechanical ventilation led to interrupt the study protocol. The decision to discharge or admit a patient was made at the end of the protocol (180 minutes) by a senior ED staff without knowledge of previous patient group allocation. Although some patients met discharge criteria during the study, none were discharged until the end of the protocol. Patients were discharged from the ED according to the following criteria: if accessory-muscle use disappeared, if wheezing was judged minimal to completely resolved, if they were free of dyspnea, and if PEF was more than 60% of predicted value. Physicians prescribed oral prednisone (40 mg for 7 days) for all discharged patients.
Measure The following parameters were measured in each patient immediately before starting the treatment and at 30 minute intervals for 3 hours after presentation: peak expiratory flow (PEF), respiratory rate (RR), heart rate (HR), dyspnea scale, systolic and diastolic blood pressure. PEF was measured with peak flow meter (mini-Wright; Clement Clarke; Harlow, UK). The highest of three values was recorded. HR was measured from continuous monitor. Dyspnea was assessed by the patient's own sensation of respiratory difficulty with a value assigned on a scale of 0 to 3, in which 0 denoted absent, 1 mild, 2 moderate, and 3 severe. At the end of the treatment, the patient was asked to indicate the presence or absence of each of five symptoms: palpitations, tremor, anxiety, headache, and dry mouth. Also, an interviewer determined the duration of symptoms before presentation, which specifically included how long the patient had been wheezing and shorter of breath than usual; a decline in the PEF, if available, was considered. The occurrence of a worsening of ventilator status requiring mechanical ventilation led to interrupt the study protocol. The decision to discharge or admit a patient was made at the end of the protocol (180 minutes) by a senior ED staff without knowledge of previous patient group allocation. Although some patients met discharge criteria during the study, none were discharged until the end of the protocol. Patients were discharged from the ED according to the following criteria: if accessory-muscle use disappeared, if wheezing was judged minimal to completely resolved, if they were free of dyspnea, and if PEF was more than 60% of predicted value. Physicians prescribed oral prednisone (40 mg for 7 days) for all discharged patients.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: